search
Back to results

Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

Primary Purpose

Candidiasis, Vulvovaginal

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Clotrimazole vaginal tablet
Fluconazole
Sponsored by
Peking University Shenzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis, Vulvovaginal

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7
  2. Subject completes the informed consent process
  3. Subject agrees to take study medication when scheduled
  4. Subject complies with all clinical trial instructions. Commits to all follow-up visits

Exclusion Criteria:

  1. had any other sexually transmitted disease or gynaecological abnormality requiring treatment
  2. had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods
  3. were pregnant
  4. had used antifungal medication in the week before entry
  5. were expected to menstruate within seven days of the start of treatment
  6. infected more than one candida species

Sites / Locations

  • Peking University Shenzhen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clotrimazole vaginal tablet

Fluconazole

Arm Description

2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)

2 doses of 150 mg oral Fluconazole (at day1 and day4)

Outcomes

Primary Outcome Measures

Therapeutic Efficacy 1
The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures.
Therapeutic Efficacy 2
The clinical cure rates of clotrimazole and fluconazol
Therapeutic Efficacy 3
Mycological cure of clotrimazole group and fluconazole group
Therapeutic Efficacy 4
Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits.

Secondary Outcome Measures

Adverse Events 1
Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.
Adverse Events 2
Vulvovaginal pruritus, burning, irritation, and bleeding
Adverse Events 3
Gastrointestinal tract: abdominal pain, diarrhoea, nausea
Adverse Events 4
Skin sensitivity, urticaria rash, erythematous rash, irritation
Total Adverse Events
Total adverse events(cases)

Full Information

First Posted
June 30, 2014
Last Updated
April 28, 2017
Sponsor
Peking University Shenzhen Hospital
Collaborators
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT02180828
Brief Title
Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
Official Title
An Case-controlled Randomized Study to the Efficacy of Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Shenzhen Hospital
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis
Detailed Description
The current study is evaluating both the efficacy and safety of the 2 doses of 500 mg clotrimazole vaginal tablet administered intravaginally( at day 1 and day 4) v.s 2 doses of 150 mg fluconazole( at day 1 and day 4) for treatment of severe vulvovaginal candidiasis.The number of participants with adverse events as a measure of safety and tolerability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Vulvovaginal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clotrimazole vaginal tablet
Arm Type
Experimental
Arm Description
2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Arm Title
Fluconazole
Arm Type
Active Comparator
Arm Description
2 doses of 150 mg oral Fluconazole (at day1 and day4)
Intervention Type
Drug
Intervention Name(s)
Clotrimazole vaginal tablet
Other Intervention Name(s)
Canesten
Intervention Description
2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Other Intervention Name(s)
Diflucan
Intervention Description
2 doses of 150 mg oral Fluconazole (at day1 and day4)
Primary Outcome Measure Information:
Title
Therapeutic Efficacy 1
Description
The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures.
Time Frame
7-14 days after treatment (=visit 2)
Title
Therapeutic Efficacy 2
Description
The clinical cure rates of clotrimazole and fluconazol
Time Frame
at days 30-35 follow-up
Title
Therapeutic Efficacy 3
Description
Mycological cure of clotrimazole group and fluconazole group
Time Frame
at days 7-14 follow-up
Title
Therapeutic Efficacy 4
Description
Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits.
Time Frame
at days30-35 follow-up
Secondary Outcome Measure Information:
Title
Adverse Events 1
Description
Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.
Time Frame
at day 7-14 follow up
Title
Adverse Events 2
Description
Vulvovaginal pruritus, burning, irritation, and bleeding
Time Frame
at day 7-14 follow up
Title
Adverse Events 3
Description
Gastrointestinal tract: abdominal pain, diarrhoea, nausea
Time Frame
at day 7-14 follow up
Title
Adverse Events 4
Description
Skin sensitivity, urticaria rash, erythematous rash, irritation
Time Frame
at day 7-14 follow up
Title
Total Adverse Events
Description
Total adverse events(cases)
Time Frame
at day 7-14 follow up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3) with a minimum VVC Composite Signs/Symptoms score of 7 Subject completes the informed consent process Subject agrees to take study medication when scheduled Subject complies with all clinical trial instructions. Commits to all follow-up visits Exclusion Criteria: had any other sexually transmitted disease or gynaecological abnormality requiring treatment had a disease known to predispose to candidiasis such as diabetes mellitus, or were receiving antibiotics or corticosteriods were pregnant had used antifungal medication in the week before entry were expected to menstruate within seven days of the start of treatment infected more than one candida species
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shangrong Fan, M.D.
Organizational Affiliation
Peking University Shenzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://onlinelibrary.wiley.com/doi/10.1111/myc.12485/epdf
Citations:
PubMed Identifier
27073145
Citation
Zhou X, Li T, Fan S, Zhu Y, Liu X, Guo X, Liang Y. The efficacy and safety of clotrimazole vaginal tablet vs. oral fluconazole in treating severe vulvovaginal candidiasis. Mycoses. 2016 Jul;59(7):419-28. doi: 10.1111/myc.12485. Epub 2016 Apr 13.
Results Reference
result

Learn more about this trial

Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

We'll reach out to this number within 24 hrs